Friday, April 12, 2019 @ 5:00 pm
Polyphor AG (SIX: POLN) today announced that the US Food and Drug Administration (FDA) has designated murepavadin as a Qualified Infectious Disease Product (QIDP) in four additional indications; hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infection, bloodstream infection and complicated intra-abdominal infection.
Under the QIDP program, which was created by the Generating Antibiotic Incentives Now (GAIN) Act of 2012 to incentivize the development of new antibiotics in response to the growing threat of antibiotic resistance, Polyphor will get certain incentives for the development of murepavadin, such as eligibility for priority review and Fast Track designation for these indications. Murepavadin already has a QIDP status for ventilator-associated bacterial pneumonia (VABP). Additionally, a five-year extension of market exclusivity will be gratned upon approval of the first QIDP indication.
"These additional QIDP designations highlight the importance of our research in this area and recognizes the innovativeness of our Outer Membrane Protein Targeting Antibiotic (OMPTA) program," says Giacomo Di Nepi, Chief Executive Officer of Polyphor. "It will give us incentives such as an expedited regulatory review to develop murepavadin in four additional indications to bring this promising antibiotic to the patients who need it the most."